Specialty Pharmaceuticals: Treatment of Asthma with Biologic Therapy and MTM

By Russel Allinson, RPh, MS

Patients with asthma have many options for treatment, including the biologic omalizumab (Xolair). Pharmacists who utilize a properly executed medication therapy management program will promote increased adherence to treatment.

Asthma is a chronic lung disease that inflames and narrows the airways, causing wheezing, chest tightness, shortness of breath, and coughing.1 It is most prevalent in children but affects individuals of all ages. It has been reported that over 22 million individuals currently have asthma; of those, 6 million are children. Causes of asthma include genetics; environmental exposure, including viral respiratory infections or airborne allergens like dust and dander or tobacco smoke; drugs like aspirin; and exercise. Because asthma cannot be cured, it is important to have good asthma control to prevent its chronic and troublesome symptoms, reduce the need to use quick-relief bronchodilators, help maintain good lung function and normal activities of daily living, and prevent asthma attacks that result in the need for acute medical care. Taking an active role in controlling asthma includes working with all clinicians on the health care team to follow an asthma action plan and avoiding asthma triggers that can make symptoms flare up. The asthma action plan shows a daily treatment regimen for the asthma patient and explains to the patient instances when they would need to contact the physician or go to the emergency department.

Some of the current options for the treatment of asthma include short- and long-term controller medicines and are used according to whether the patient needs quick relief from exacerbations or to prevent symptoms from starting. The preferred option for short-term control medicines includes inhaled short-acting beta2 agonists, which act to open the airways quickly by relaxing tight muscles around the airway. These inhalers should be carried with the patient at all times and used when the patient first notices symptoms. If these inhalers need to be used more than twice a week, the patient should reconsider their asthma control and subsequently have their asthma action plan modified. Some of the current options for long-term control medicines include inhaled corticosteroids, which act to relieve airway inflammation from inhaled triggers, and inhaled long-acting beta2 agonists, which act to open the airways.

If both of these options fail in controlling exacerbations, however, other options like biologics do exist for treatment. Omalizumab (Xolair) is a recombinant DNA-derived humanized monoclonal antibody biologic product that is indicated for use in patients with moderate- to-severe persistent asthma who are inadequately controlled by inhaled corticosteroids.2 Contraindications to the use of omalizumab include having severe hypersensitivity reactions to omalizumab or any of its ingredients. Anaphylactic reactions that can develop, as indicated by the black box warning, include bronchospasm, hypotension, syncope, urticaria, and angioedema of the throat and tongue. Other serious reactions that have been observed in clinical studies include malignancies and eosinophilic conditions upon slow discontinuation of oral corticosteroid therapy.

Omalizumab works by inhibiting the binding of immunoglobulin (Ig) E to the IgE receptor on the surface of mast cells and basophils, thereby decreasing the release of mediators of the allergic response. Dosing for omalizumab is in the range of 150 to 375 mg injected under the skin every 2 to 4 weeks; the precise dose required depends on the serum IgE level and body weight in kilograms. It should be first administered in a health care setting prepared to deal with possible anaphylactic reactions. Doses greater than 150 mg should be injected in separate sites so that no more than 150 mg is given at one site. Common adverse reactions observed in patients taking omalizumab include arthralgias, leg pain, fatigue, dizziness, pruritus, dermatitis, and earache. To report these or more serious adverse reactions, contact the FDA (800-FDA-1088 or www.fda.gov/medwatch) or Genentech (888-835-2555).

In order to understand the uniqueness, complexity, and risks associated with using a biologic medication for the treatment of chronic asthma symptoms, one should consider how it will be used and monitored in a medication therapy management (MTM) program. The MTM program will help to achieve proper asthma control while reducing asthma-related morbidities and mortalities and thereby health care costs. Five core elements that should be implemented in a properly executed MTM program for omalizumab—consistent with the MTM pharmacy practice service model—include:

(1) conducting a medication therapy review

(2) creating a personal medication record

(3) creating a medication-related action plan

(4) intervention and referrals

(5) and documentation of all work with offered follow-up.3

The medication therapy review will have the pharmacist collect patient-specific information and assess medication therapies to identify medication-related problems with a subsequent plan to resolve them. At the end of the consultation, the pharmacist can provide patient education to improve the management of the patient’s medications and teach him or her how to monitor and manage potentially serious side effects like anaphylaxis.

The personal medication record is a comprehensive record of the patient’s prescription and nonprescription medications that is typically updated when the patient receives a new medication, has a current medication discontinued, or has an instruction changed. It is important to document these changes in the medication record. The medication-related action plan is used to track progress of medication self-management and contains a list of patientdirected action items that are within the pharmacist’s scope of practice. For omalizumab, having the patient report any unusual reactions upon taking it should be emphasized.

Intervention and referral involves the pharmacist communicating important information from the MTM interview to the prescribing physician when a medication-related problem is encountered that is beyond the scope of immediate practice and that requires intervention. Some of the pharmacist interventions that can be communicated to the prescriber include ensuring accurate dosing, consulting on alternative medications for managing severe adverse reactions, suggesting the addressing of medication problems that may reduce adherence, and recommending followup care. Finally, pharmacists should document all services and interventions for evaluating patient progress and submission to billing. The record should be ongoing and list the care provided in chronological order in a SOAP (subjective, objective, assessment, and plan) note format.

Asthma is a chronic disease that has no known cure. Symptom control is paramount to avoiding asthma-induced exacerbations that cause an increase in morbidity and mortality. If patients are refractory to traditional therapies like short- and long-acting beta2 agonists or inhaled corticosteroids, then omalizumab should be considered as an alternative for moderate-to-severe persistent chronic asthma. Because omalizumab has increased dosing complexity and risks associated with its use, it requires increased pharmacist support and consistent monitoring to ensure proper use and optimal outcomes. Consistent pharmacist monitoring as part of a comprehensive MTM program will promote decreased morbidity and increased adherence, resulting in positive therapeutic outcomes and an improvement in the patient’s quality of life.

Mr. Allinson is chief executive officer and chief clinical officer of Therigy, LLC.

References

• NHLBI. Asthma. National Heart Lung and Blood Institute Web site. Diseases and Conditions Index. www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_Causes.html. Accessed March 23, 2010.
• Xolair Package insert. Updated 1-10.
• American Pharmacists Association, National Association of Chain Drug Stores Foundation. Medication therapy management in community pharmacy practice: core elements of an MTM service. Version 2.0, March 2008. www.pharmacist.com/AM/Template.cfm?Section=Pharmacist_Practitioners&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=15639. Accessed March 23, 2010.